Kornimate/medical-research-clean huggingface dataset:
survey on pd patients with depressive symptoms

Conditions: Parkinson Disease

Summary: the primary objective of this investigation is to conduct a 12-week prospective survey in pd patients with depressive symptoms treated with bi sifrol tablets (hereinafter referred to as this drug) in the routine clinical settings to determine the following items related to the safety and efficacy. i. adverse drug reaction symptoms, incidence, and severity ii. motor capacity during the investigation iii. depressive symptoms during the investigation


Eligibility criteria:
inclusion criteria: \*\*pd patients with depressive symptoms patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance. exclusion criteria: * pd patients with the past history of suicidal attempt, suicidal ideation or tendency * pd patients with suicidal ideation * pd patients with the past history of suicidal tendency
hp184 in chronic spinal cord injury subjects

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to determine whether hp184 is effective in the treatment of chronic spinal cord injury (csci).


Eligibility criteria:
inclusion criteria: * male and female subjects with incomplete (traumatic), chronic (defined as 18 months or more post spinal cord injury) sci aged 18 to 65 years * csci must be categorized in classes c or d in the asia impairment scale. (c = incomplete impairment with motor function preserved below the neurological level, and more than half of key muscles below the neurological level have a muscle grade less than 3. d = incomplete impairment with motor function preserved below the neurological level, and at least half of key muscles below the neurological level have a muscle grade more than or equal to 3). * the level of the sci must be between c4 and t10 (neurological) * subject has a measurable range of motion at the hips, knees and ankles and possesses potential propulsive activity (i.e. no functional contractures) * female subjects of childbearing potential (those who are not surgically sterile or who are less than 2 years postmenopausal) must be using two forms of birth control, including a primary and a secondary form and have a negative pregnancy test immediately prior to treatment. primary forms of contraception include: tubal ligation, partner's vasectomy, intrauterine devices, birth control pills, and topical/injectable/implantable/insertable hormonal birth control products. secondary forms of contraception include diaphragms, latex condoms and cervical caps; each must be used with a spermicide. exclusion criteria: * any clinical evidence of recent fracture(s) within the last six months prior to study start. * any history of multiple sclerosis or peripheral demyelinating disease or neuromuscular disorder. * heart rate of less than 38 or greater than 100 * ashworth spasticity score of 0/4 or 4/4 at the hip or knee. * subject whose medical condition requires mechanical ventilation. * lower motor neuron injury, such as those with conus medullaris or cauda equina injuries. * subject with lower extremity amputation or proximal femorectomy. * subject with pressure ulcers stages 3 and 4. * subject medically or mentally unstable in judgment of investigator. * subject on tricyclic antidepressants such as nortriptyline, amitriptyline and imipramine. * subject with asia motor score of greater than or equal to 92. * subject with asia sensory score of greater than or equal to 200. * subject with history of seizure within 2 years prior to study start. * subjects who have participated in a clinical trial involving investigational medication within 30 days prior to administration of hp184 or placebo. * female subjects with positive urine pregnancy test. * female subjects who are breast feeding.
effect of co2 laser on enamel white spot lesion formation around orthodontic brackets

Conditions: White Spot Lesion

Summary: this study aims to evaluate the clinical effect of co2 laser on enamel resistance to white spot lesions formation around orthodontic brackets. 25 patients needing fixed orthodontic treatment will participate in the study, the co2 laser will be applied in a split mouth design around orthodontic brackets in two contrast quarters of mouth in every patient and the other quarters will serve as a control. the white spot lesion formation will be monitored around the brackets during the orthodontic treatment after four and twelve weeks of irradiation with laser.

prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. the operator will inform them about the aim of the study and ask them to provide a written informed consent. before brackets' bonding (t0) the operator will evaluate with intraoral clinical examination and take intraoral photographs and evaluate with diagnodent. then after brackets' placement on teeth, the co2 laser will be applied to the area of enamel about 2 mm of width around orthodontic brackets in a split mouth design. to blind the intervention sides on patients the control sides will receive nontherapeutic light. then intraoral photographs will be taken and the teeth will be assessed with diagnodent (t1). all patients will be trained to brush their teeth with a tooth paste containing 1100 ppm of fluoride twice a day. after 4 weeks of irradiation (t2) the patients will be examined for white spot lesions formation by clinical examination using geiger index, photographic examination using autocad 2009 evaluating formation and area percentage of white spot lesions, and the degree of demineralization will be assessed with diagnodent. the all exams will also be done after 12 weeks of irradiation (t3).

Eligibility criteria:
inclusion criteria: * adult patients with permanent occlusion at age 15-25 years. * no previous orthodontic treatment * good oral hygiene * need to orthodontic treatment with fixed appliances exclusion criteria: * patients with systemic diseases or syndromes * patients with existence of enamel fluorosis * patients with existence of amelogenesis imperfecta or hypocalcified enamel * patients with existence of restorations or crowns or carious lesions on the labial surfaces of teeth. * patients who received fluoride treatment within the last three months prior to being enrolled in the study.
the effect of gum chewing on postoperative ileus after gynecologic surgery

Conditions: Postoperative Ileus

Summary: the investigators are randomizing patients to receive chewing gum (extra sugar free, spearment) every 4 hours during waking hours for 15 minutes versus standard postoperative care. the investigators then have them fill out a survey in house and 1 week after their surgery that record time to first flatus, hunger, toleration of clear liquids and food and some information about pain, satisfaction, and quality of life. the investigators contact them via phone and email a maximum of three times in order to collect this information. 30 days postoperatively the investigators also contact them and perform a chart review for any postoperative complications.


Eligibility criteria:
inclusion criteria: * 18 years or older * undergoing benign gynecologic surgery via an exploratory laparotomy * capable of giving consent exclusion criteria: * oromaxillary or mental disturbances that would make chewing gum dangerous with regards to mastication or aspiration * intubated or unconscious when leaving the or * bowel resection performed at the time of surgery * active bowel disease (ibd, appendicitis, etc) * gynecologic malignancy
validity of korebalance balance system

Conditions: Osteoporosis, Postmenopausal; Balance; Distorted

Summary: in postmenopausal osteoporosis patients, the balance is impaired. equilibrium is evaluated with various test and balance systems. this study aims evaluation of the patients with the korebalance balance system and balance tests and investigation the validity of the korebalance balance system.

53 postmenopausal osteoporosis patients were evaluated with balance tests (berg balance scale (bbs) and timed up and go test (tug)) and korebalance balance system. the korebalance balance system is a balance assessment and exercise system. the higher the score, the greater the deterioration in the balance. the results of static and dynamic balance evaluation are recorded as score values. in this study, investigators compared korebalance balance system, berg balance scale (bbs) and timed up and go (tug) tests and other demographic and clinical parameters (age, body mass index (bmi), 25ohvitd level, menopause age, fall within the last 1 year, fracture history, history of fracture in mother).

Eligibility criteria:
inclusion criteria: * having postmenopausal osteoporosis * no other disease that can cause balance disorder * volunteer participation in the study exclusion criteria: * to have a disease that will cause balance disorder, * having understanding problem to prevent communication with the patient, * the lack of motor function to the balance device.

Keywords: osteoporosis balance berg balance scale korebalance balance system
bacillus subtilis in parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this study is to evaluate whether the administration of bacillus subtilis influences gut and blood biomarkers relevant to the proposed mechanism(s) of action, as well as being acceptable as a regular supplement for people with parkinson's disease.

following informed consent, participants will undergo screening. if eligible, they will be invited to attend a baseline visit (week 0) to complete clinical assessments and provide a faecal and blood sample before starting their assigned intervention. each participant will be randomised 1:1 to visually identical capsules containing either bacillus subtilis or placebo to be taken for 24 weeks. telephone follow-up will be performed at week 8 to ensure compliance and answer any participant questions. repeat clinical assessments and faecal/blood sample collection will take place at weeks 24 (treatment end date) and 36 (to assess longevity of biomarker changes after the intervention has stopped). faecal samples will be collected at home within seven days prior to the clinic visits and brought to the appointment. microbiota composition in faecal samples and blood biomarkers will be analysed in participant samples. motor and non-motor symptom rating scales will also be administered.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease * able to provide written informed consent * over 50 years old * motor symptom duration over 12 months * stable dopaminergic medication regime for at least 3 months exclusion criteria: * use of probiotic supplements and probiotic-fortified foods (such as probiotic drinks and yoghurts) within past 3 months * use of antibiotics within past 3 months * previous gastrointestinal surgery or chronic organic bowel disorder * history of clinically significant motor fluctuations * history of postural instability or falls * current smoker * known or suspected allergy to probiotics * regular use of antacids, proton pump inhibitors, laxatives or anti-diarrheal drugs * use of hypoglycaemic or diabetes drugs * participation in clinical trial of investigational medicinal product within past 3 months * co-morbidities or other factors that, in the opinion of the investigator, make the patient unlikely to comply with study protocol

Keywords: probiotic microbiome
dorado-ac-ex - a long-term safety extension study to the phase 3 doradoc-ac study (protocol dar-312) of darusentan in resistant hypertension

Conditions: Hypertension

Summary: this is a double-blind, active-controlled, long-term study of a new experimental drug called darusentan. darusentan in not currently approved by the united states food and drug administration (fda), which means that a doctor cannot prescribe this drug. the purpose of this study is to evaluate the long-term safety of darusentan (optimized dose) as compared to an active control, administered orally.


Eligibility criteria:
selected inclusion criteria: 1. subjects must be competent to provide written informed consent; 2. subjects must have completed the maintenance period of the dar-312 study. selected exclusion criteria: 1. subjects who discontinue treatment with study drug prior to the end of the maintenance period in dar-312 due to a study drug-related ae; 2. subjects who experience a study drug-related serious adverse event (sae) during the dar-312 study.
efficacy study of iv fluids only vs ondansetron to treat dehydration

Conditions: Dehydration; Gastroenteritis

Summary: dehydration due to vomiting is a common complication of acute gastroenteritis in children. persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy. four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial \[1-4\]. a previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients \[5\]. none of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . in addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures. the proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. if ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. if it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved. hypothesis: patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.


Eligibility criteria:
inclusion criteria: * age 6 months - 5 years * clinical diagnosis of acute gastroenteritis * mild or moderate dehydration as determined by validated clinical scale * clinical assessment to begin iv fluids * vomiting ≥ 2 episodes in past 4 hours exclusion criteria: * severe dehydration * history of significant gastrointestinal, metabolic, renal or cardiac disorder * ondansetron allergy * non-english language proficient parent/guardian * parent/guardian has no telephone

Keywords: dehydration acute gastroenteritis ondansetron rehydration
improving hand use in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this study will compare two different kinds of physical therapy to improve use of the hands in individuals with multiple sclerosis (ms). one treatment will be constraint-induced movement therapy (ci therapy), the other will be a set of complementary and alternative medicine (cam) treatments (yoga, relaxation exercises, aquatherapy, massage). the study will determine which of the two forms of treatment is more successful for improving hand use.

multiple sclerosis (ms) frequently causes reduced use of one of the hands, and as a result, much of daily living activities are conducted only by the other hand, leaving the person effective one-handed. nonetheless, reduced hand use can be improved for extended amounts of time with specific forms of physical therapy, as long as persons with ms have the ability to perform the training tasks. this study will randomize persons with ms who have relatively reduced use of one of the hands to either ci therapy or cam treatments. treatment in either program will be for 2 consecutive weeks, 3.5 hours per day (monday-friday), under the direct supervision of a specially trained therapist. before starting, participants will also undergo comprehensive medical and physical exam screening and brain mri scan. the same evaluations will be performed after treatment to learn whether any of these have changed as a result of treatment.

Eligibility criteria:
inclusion criteria: * diagnosis of non-relapsing multiple sclerosis (primary progressive ms, secondary progressive ms) * reduced use of one of the hands because of ms * ability to pick up and release a small object with the more-affected hand when requested * can travel to the treatment program at the university of alabama at birmingham (uab) * can undergo treatment for 2 weeks (monday-friday), 3.5 hours per day * can undergo mri scan * any kind of medication used for ms is allowed except spasticity medicine exclusion criteria: * disease relapse in the past 3 months * pregnancy * marked pain with arm movement * severe uncontrolled medical illness * simultaneous treatment with another form of physical therapy

Keywords: multiple sclerosis ms ci therapy cimt constraint-induced movement therapy complementary and alternative medicine cam physical therapy occupational therapy relaxation exercise massage yoga pool therapy aquatherapy aquatic therapy
optimizing duration of therapist-guided internet-delivered cognitive behaviour therapy

Conditions: Anxiety; Depression

Summary: depression and anxiety are common and prevalent conditions that are frequently under treated. in an attempt to increase timely and accessible psychological treatment, internet-delivered cognitive behaviour therapy (icbt) has emerged. icbt involves delivering therapeutic content to manage depression and or anxiety via structured online lessons. this is often combined with brief therapist guidance, for example once per week for 8 weeks via secure messaging or phone calls. although outcomes of icbt are very impressive, there is room for improvement in terms of completion rates and outcomes. feedback from patients suggest that some patients would prefer longer term support or follow-up care. in this two-factorial randomized controlled trial, the investigators aim to contribute to the literature by examining whether the efficacy of icbt is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) and being offered a booster session at 16 weeks after treatment enrollment (yes vs no). follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. primary outcomes are reduced anxiety and depression. secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use.

past research of icbt offered in routine care has found that patients and therapists often recommend "personalizing" the delivery of icbt, for example, by increasing the length of time therapist support is available or offering booster sessions after treatment has ended. to date, in terms of icbt, there has been limited research on the impact of extending support after treatment materials have been delivered or offering a booster session. in this trial, the investigators will examine if the efficacy of icbt is improved by offering an extended period of support to clients (from 8 weeks to 12 weeks) or by being offered a booster session at 16 weeks after treatment enrollment (yes vs no). follow-up assessments will be conducted at 8, 16 and 26 weeks after treatment enrollment. primary outcomes are reduced anxiety and depression. secondary outcomes include reduced panic, social anxiety, trauma, quality of life, disability, work productivity, and healthcare use. the impact of these factors on intervention usage (e.g., completion rates, log-ins, emails sent) and treatment satisfaction will also be examined.

Eligibility criteria:
inclusion criteria: * 18 years or older * endorse symptoms of anxiety or depression * resident of saskatchewan * access to a computer and the internet exclusion criteria: * have a severe psychiatric illness (e.g. psychosis) * assessed as being at high risk of suicide * report severe problems with alcohol or drugs * report severe cognitive impairment

Keywords: anxiety depression internet-delivered cognitive behaviour therapy randomized controlled trial patient-centred personalized therapy knowledge implementation mental health system therapist-assistance booster session factorial design
early precise diagnosis and intervention of cpt based on a noninvasive 3d-vhps

Conditions: Portal Hypertension; Cirrhosis

Summary: the aim of this study is to investigate the possibilities of early and precise management to decrease portal vein pressure in cirrhotic patients, guided by a non-invasive 3d-virtual-model of hepatic portal system (3d-vhps). healthy volunteers are enrolled to determine the normal range of pressure density in different sites of hps. cirrhotic patients without visible gastro-esophageal varies by endoscopy are randomly enrolled to virtual portal vein pressure gradient (vpvpg) monitored or non-vpvpg monitored groups. non-vpvpg groups are followed-up and treated according to baveno v consensus in portal hypertension. patients in vpvpg-monitored groups are followed-up by anatomic computed tomographic angiography (cta) and doppler ultrasound every six months. once vpvpg is above 12mm of mercury (hg), participants will receive carvedilol treatment. all cirrhotic patients are followed-up with the incidence of portal hypertension-related complications, mortality rate and life quality assessment.

the non-invasive 3d-hps is a newly-developed test to determine vpvpg based on anatomic computed tomographic angiography (cta) and doppler ultrasound. in this study, vpvpg is determined by the 3d-hps.

Eligibility criteria:
inclusion criteria: * proven cirrhosis based on histology or unequivocal clinical, sonographic and laboratory findings * child-pugh score \< 9 * no visible gastro-esophageal varies by endoscopy exclusion criteria: * patients with malignant diseases * treatment with vasoactive drugs * prior transjugular intrahepatic portosystemic stent-shunt surgery * patients with known allergy to iodinated contrast * treatment with immunosuppressants * renal sufficiency * patients with coronary artery diseases, or treated with anticoagulants * pregnancy * inability to adhere the follow-up * any life-threatening disease
anesthesia for catheter aortic valve implantation registry

Conditions: Heart Failure; Excessive Amount of Blood / Fluid Transfusion; Intraoperative Cardiac Arrest During Cardiac Surgery; Critical Incident; Anesthesia; Failed Conscious Sedation During Procedure

Summary: in modern cardiac surgery and cardiology transcatheter aortic valve implantation (tavi) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable. the investigators want to evaluate the specific intraoperative anesthesiologic characteristics cardiac anesthesiologists have to face during these procedures.


Eligibility criteria:
inclusion criteria: - patients undergoing transcatheter aortic valve implantation (tavi) exclusion criteria: - refusal by patient